Kornimate/medical-research-clean huggingface dataset:
ketorolac sublingual vs. fentanyl intranasal in pain control for bilateral myringotomy and tubes (bmt) placement in children

Conditions: Pain, Postoperative; Otitis Media

Summary: the purpose of this study is to compare the efficacy and safety of ketorolac sublingual with fentanyl intranasal used in our hospital for pain control in children undergoing bilateral myringotomy with placement of pressure equalization tubes (bmts).

this prospective, randomized, allocation concealed blinded study is designed to compare ketorolac sublingual vs. fentanyl intranasal vs. the combination of these two medications for pain control after bmts in children. bilateral myringotomy and tube placement is an elective operation, mainly in the pediatric population.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist (asa) i-ii physical class * scheduled for elective bmt * mask induction of anesthesia exclusion criteria: * allergy to any nsaids * severe upper respirator infection * severe asthma * bleeding disorders * history of gi bleeding * renal impairment * scheduled for one-sided myringotomy and tube placement
unrelated double umbilical cord blood units transplantation

Conditions: Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute; Leukemia, Myeloid, Chronic

Summary: the purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units transplantation in patients with haematological malignancies using antithymocyte globulin cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as gvhd prophylaxis.


Eligibility criteria:
inclusion criteria: * hematologically \& histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in remission * aged 1 year to 50 years * absence of hla compatible related or other related donor. * availability of suitable ucb units. * karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) : 80- 100 * adequate renal function defined as:serum creatinine \<1.5 x normal, * adequate liver function defined as:total bilirubin \<1.5 x normal, or sgot (ast) or sgpt (alt) \<3.0 x normal * adequate cardiac function defined as: ejection fraction \>50% by echocardiogram. * adequate pulmonary function defined as:uncorrected dlco 50% by pulmonary function test.for children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air exclusion criteria: * age: \ 50 year * patients with an available 5-6/6 hla-a, -b, -drb1 matched sibling or other related donor * karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) \< 80 * hiv positive patients. * female patients who are pregnant or breast feeding * life expectancy severely limited by diseases of vital organs other than the disease indication for transplant * serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection * serious psychiatric/ psychological disorders * absence of /inability to provide informed consent * clinical or paraclinical evidence of cns or pns involvement

Keywords: aml all cml
dose ranging study of rimegepant (bms-927711) for the acute treatment of migraine

Conditions: Migraine; Acute Treatment of Migraine

Summary: the primary purpose of this study is to evaluate the efficacy of rimegepant (bms-927711) compared with placebo in the acute treatment of migraine as measured by pain freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the phase 3 clinical trials.

intervention model: parallel versus comparator + placebo

Eligibility criteria:
key inclusion criteria: * patient with at least 1-year history of migraines (with or without aura) including the following: * migraine attacks more than 1 year with age of onset prior to 50 years of age * migraine attacks, on average, last about 4 - 72 hours if untreated * no more than 8 attacks of moderate to severe intensity per month within last 3 months * patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months * less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening * male and female ≥ 18 years and ≤ age 65 * no clinically significant abnormality identified on the medical or laboratory evaluation key exclusion criteria: * patient has a history of basilar migraine or hemiplegic migraine * patient does not receive migraine relief from triptan migraine treatment * medications that may alter the ph of the stomach (acid reducing agents), such as h-2 antagonists, proton pump inhibitors (ppi), antacids * history of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months * history of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months
safety and efficacy study of bosentan for intermittent claudication in peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: a prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind was performed in 30 male patients (50-60 years old) with intermittent claudication (rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6 months with hypertension and/or dyslipidemia as unique co-morbility disorders. after a period of stabilization of the claudication distance in the stress test (12.5%, 3.2 km/h) during 2 weeks, were randomized 1:1 to the experimental arm (bosentan 62.5 mg twice daily/four weeks and 125 mg twice daily/eight weeks) or control group.


Eligibility criteria:
inclusion criteria: * arterial hypertension and hypercholesterolemia * abi \<0,9 * positive claudiometry with a claudication distance between 50 and 500 exclusion criteria: * surgical patient * previous revascularization procedure in the member studied * smoker * uncontrolled hypertension * cardiac stress test unfinished * prior dvt * concomitant severe disease * obesity

Keywords: bosentan peripheral arterial disease
an open-label study of the safety and efficacy of cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with aids

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to evaluate the safety and tolerance of cidofovir (hpmpc) infusions in aids patients with relapsing cytomegalovirus (cmv) retinitis. to determine the time to retinitis progression in this patient population. to evaluate the impact of cidofovir therapy on visual acuity.

patients are randomized to receive intravenous hpmpc either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. induction consists of two consecutive weekly doses followed by maintenance every other week. all patients receive concomitant probenecid and saline hydration. treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiretroviral agents. * oral trimethoprim/sulfamethoxazole. * aerosolized pentamidine. * dapsone. * fluconazole. * rifabutin. * filgrastim (g-csf). * itraconazole. * hiv vaccines. patients must have: * aids. * cmv retinitis, with severity as specified in the disease status field. * life expectancy of at least 3 months. * consent of parent or guardian if less than 18 years of age. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known clinically significant allergy to probenecid. * clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. * other active medical problems sufficient to hinder study compliance. concurrent medication: excluded: * amphotericin b. * aminoglycoside antibiotics. * vidarabine. * intravenous pentamidine. * cmv hyperimmune immunoglobulin. * other nephrotoxic or potentially nephrotoxic agents. * other investigational agents with anti-cmv activity. * ganciclovir. * intravenous or oral acyclovir (except following development of herpetic lesion). * foscarnet. * diuretics. prior medication: excluded within 2 days prior to study entry: * ganciclovir or foscarnet. excluded within one week prior to study entry: * amphotericin b. * aminoglycoside antibiotics. * vidarabine. * intravenous pentamidine. * cmv hyperimmune immunoglobulin. * other nephrotoxic agents. * other investigational agents with anti-cmv activity. excluded at any time: prior systemic or intravitreal hpmpc. drug or alcohol abuse that is considered sufficient to hinder study compliance.

Keywords: retinitis probenecid drug therapy, combination cytomegalovirus infections acquired immunodeficiency syndrome antiviral agents cidofovir
the natural history of mucolipidosis type iv

Conditions: Mucolipidosis Type IV

Summary: the purpose of this study is to define the natural history of mucolipidosis type iv and identify potential clinical outcome measures.

mucolipidosis type iv (mliv) is an autosomal recessive disorder typically characterized by severe psychomotor delay evident by the end of the first year of life and slowly progressive visual impairment during the first decade as a result of a combination of corneal clouding and retinal degeneration. by the end of the first decade of life, and always by their early teens, individuals with typical mliv develop severe visual impairment as a result of retinal degeneration. mliv is an under-diagnosed and unique lysosomal disorder in that it often is mistaken either for cerebral palsy or for a retinal dystrophy of unknown cause. in addition, it is caused by a defect in a cation channel rather than by a lysosomal hydrolase. this study represents the only prospective clinical study in this patient population. now that an animal model has been created and novel therapies will likely be tested, it is particularly important to define the natural history of this disorder and identify potential clinical outcome measures.

Eligibility criteria:
inclusion criteria: subjects must: * have a definitive diagnosis of mliv based at least on a compatible history and significantly elevated blood gastrin levels * be able to travel to the baylor institute of metabolic disease in dallas and spend 2-3 working days on site * be able to tolerate a general exam and neurological exam * be able to tolerate a modest amount of blood drawing, provide a urine specimen, and have a skin biopsy(if not previously done) * be able to tolerate the performance of necessary neuroimaging studies to include eeg and head mri * be able to tolerate a neuropsychological testing and rehabilitation evaluation exclusion criteria: -

Keywords: mucolipidosis, retinal dystrophy, mucolipin-1, lysosomal storage disease, gastrin, mental retardation, dysmyelination, dysplastic corpus callosum,corneal clouding
serial ultrasound of solid tumor lesions to detect early response to cancer immunotherapy

Conditions: Solid Tumor

Summary: primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by ceus, can predict initial objective response to therapy, defined by current standard-of-care secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (ceus or conventional power doppler or lead ultrasound) or optimal time point to predict initial objective response and to assess the correlation of tumor perfusion parameters with change in overall tumor burden, change in diameter on a per-lesion basis, and with 12-month progression-free survival (pfs).


Eligibility criteria:
inclusion criteria: * 18 years of age or older * pathology-confirmed diagnosis of cancer * at least one solid tumor lesion greater than 1 cm in diameter (primary tumor and/or at metastatic site), amenable to ultrasound imaging * planned to be treated with ici therapy (single agent or in combination with any other drug) * written informed consent. * prior use of any ici is not necessarily excluded, and patients may be included with the approval of the protocol director subjects may participate in the study more than once at the discretion of the protocol director, for example, if they receive different lines of treatment that all qualify for the study. exclusion criteria: * known hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (peg) * any comorbid condition that, in the opinion of the treating provider or the protocol directors, compromises the participant's ability to participate in the study * examples: any mental condition that compromises the ability to follow a consent discussion, or to make informed decisions (except if represented by a legally authorized representative \[lar\]), or to have ultrasound exams.
apatinib in combination with stereotactic body radiation therapy (sbrt) treatment for symptomatic metastatic prostate cancer

Conditions: Quality of Life

Summary: to study safety and efficacy of apatinib in combination of radiotherapy in patients with symptomatic bony disease prostate cancer (sbpc), based on the potential synergistic antitumor activity between apatinib and stereotactic body radiation therapy (sbrt).


Eligibility criteria:
inclusion criteria: * histologic diagnosis of adenocarcinoma of the prostate * metastatic and symptomatic prostate cancer (positive bone scan or measurable disease) * patients must stop using any herbal product known to decrease psa levels (eg., saw palmetto and pc-spes) or any systemic or topical corticosteroid at least 4 weeks prior to screening. progressive disease must be documented after discontinuation of these products. * progressive disease after androgen deprivation (or hormone therapy). for patients with measurable disease, progression will be defined by response evaluation criteria in solid tumors (recist) criteria. for patients with progression in, or without any measurable disease, a positive bone scan and elevated psa will be required. * patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment. * no prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer). * prior radiation therapy completed at least 4 weeks prior to enrollment. no prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. exclusion criteria: * history of severe hypersensitivity reactions to drugs formulated with polysorbate 80. * patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo. * prior therapy with any anti-cytotoxic t-lymphocyte antigen 4 (anti-ctla-4) antibody. * active infection requiring therapy. * concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. the use of inhaled corticosteroids is acceptable.
gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how will patients respond to treatment. purpose: this research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.

objectives: * to identify 100 patients from the head and neck tumor tissue repository and clinical database treated with cetuximab monotherapy or cetuximab-containing combination therapy as a standard of care for recurrent and/or metastatic head and neck squamous cell carcinoma at vanderbilt university medical center. * to assay the diversity of gene and protein expression patterns seen in these patients. * to identify predictive patterns associated with treatment response and survival of these patients by correlating the laboratory data with clinical data. outline: tumor tissue specimens and clinical data are obtained from the head and neck tumor tissue repository and clinical database protocol vu-vicc-hn-0356. specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by dna microarray, tissue microarray, reverse transcriptase-pcr, and mass spectroscopy.

Eligibility criteria:
disease characteristics: * diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma * enrolled on the head and neck tissue repository and clinical database protocol vu-vicc-hn-0356 * previously treated with cetuximab monotherapy or cetuximab-based combination therapy * sufficient biological material available for analysis patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the larynx stage iv verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage iv squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage iv verrucous carcinoma of the oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx stage iv squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage iv squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage iv salivary gland cancer
long-term follow-up of the safety and efficacy of rct-01 in men and women with unilateral, chronic achilles tendinosis

Conditions: Tendinosis; Tendinopathy

Summary: the primary purpose of this study is to assess the long-term safety profile of rct-01 injections as compared to placebo injections. this study will also measure the long-term impact these injections will have on tendon structure and function and the symptoms of achilles tendinosis. this is study is designed to follow participants who have completed participation in a clinical trial where they received injections of either rct-01 or placebo in the achilles tendon. no clinical interventions will be performed as part of study procedures. the day of study entry (visit 1) will be coordinated with the participant's final visit in the earlier clinical trial. all participants will return to the clinic for repeat assessments of their achilles tendinosis and overall health 6, 12 and 18 months after study entry. furthermore, they will complete 'telephone visits'; during which they will report information on their overall health; 3, 9, and 15 months after study entry. total duration of patient participation is approximately 18 months.


Eligibility criteria:
inclusion criteria: * participation in a clinical trial designed to evaluate rct-01 treatment for chronic achilles tendinosis. participants must complete the final study visit in the earlier trial prior to participation in this clinical trial. * willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol. exclusion criteria: * the presence of any condition that, in the investigator's opinion would impact participant safety and/or a participant's ability to complete all study related procedures. (e.g., psychiatric illness, drug addiction, alcoholism, etc.) note: age limits not specifically set in this trial as entry into current trial based on qualification/completion of previous clinical trial where age rage of participants was explicitly stated.
biodegradable stents in lung transplantation

Conditions: Lung Transplantation

Summary: a prospective observational trial involving 10 patients is planned. intervention "sx-ella stent degradable dv bronchial (dv stent)" will be implanted in the target lesion in general anesthesia under fluoroscopy or by direct vision. before dilatation, extension of the airway complications will be measured by bronchoscopy and documented.

obstructive airway complications (oac) (bronchial stenosis) are a significant problem in lung transplantation (ltx), and a special subset of chronic graft dysfunction. the overall rate is approximately 20% per recipient. even though disobliteration (laser, argon-coagulation, cryotherapy) or balloon dilatation (bronchoplasty) are performed there is a high rate of recurrence. self expandable metallic stents (sems) is one suggested treatment option after failed initial therapy but have a high rate of re-stenosis (50-60%). morbidity, the risk for e.g. infection and atelectasis and lower long-term survival are often consequences in pts. treated with sems. no surgical options aside from re-do-transplantation are available. oac are developing mostly in the time 3 - 6 months post tx. the idea is a permanent but temporary therapy with replacement character of the stenosis which is given in degradable bronchial stents. hypothesis: new biodegradable bronchial stents are a successful treatment of benign bronchial stenosis after lung transplantation. after stent placement is further disobliteration is less frequently used during the next 6 months.

Eligibility criteria:
inclusion criteria: * recurrent airway complication (obstructive or necrotic) after single-order double-lung transplantation (at least twice balloon-dilatation or disobliteration therapy). * patient at least 3 months after lung transplantation and followed in mhh outpatient clinic. * target lesion in the left or right main stem bronchus, intermediate bronchus, right or left lower lobe, left upper lobe. multiple lesions are eligible for inclusion and treatment but dv-stent implantation in different target lesions should be at least 6 weeks apart. exclusion criteria: * pregnant or breast feeding women. * patients who are using no double-barrier method of birth control. * previous use of a metallic stent (sems). * target lesion in the middle lobe bronchus, right upper lobe, carina or trachea. * previous use of brachytherapy or topical mitomycin. * pats. after heart-lung transplantation.

Keywords: lung transplantation bronchial stenosis biodegradable stent